MAUDE Adverse Event Report: VASONOVA INC. VASCULAR POSITIONING SYSTEM; VPS G4 SYSTEM

Catalog Number VPS-G4C

Device Problems False Device Output (1226); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Injury (2348)

Event Date 07/07/2015

Event Type  Injury  

Event Description

It was reported that the procedure was being performed in the intensive care unit.During insertion of a bard 5fr triple lumen catheter the clinician received a blue bullseye with the vps.Additional information provided by the teleflex clinical education manager indicates the clinician turned on vps unit when they were 10cm into the vessel.Initial symbol was green with low amplitude ante-grade doppler, then it went orange with retrograde flow.Kept toggling between green and orange symbols.After several frames of retrograde flow with orange symbol, symbol turned green and doppler became high amplitude ante-grade flow for several frames.There were a couple fleeting blue bullseyes followed by a steady blue bullseye for at least 10 seconds.Over the weekend, a subsequent chest x-ray was taken for another reason and reading radiologist noticed that the piccc was over the clavicle and terminated on the left side of the heart indicating aorta placement.Vascular surgery was consulted, patient was found with no brachial pulse.The patient was taken to surgery for a thrombectomy and catheter was removed.The patient had no further adverse effects.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Device evaluation: the reported complaint was confirmed through evaluation of the returned console and dataset.The x-ray mentioned in the initial report was not provided.The console was examined and found to be in acceptable condition.The unit was tested and functioned as intended and a review of manufacturing records did not yield any relevant findings.The senior algorithm scientist reviewed the saved procedure dataset and determined that the operator continued to advance the stylet in the direction of the heart even though the "orange stop" symbol and arterial flow doppler were continuously displayed after initial placement in the peripheral site.This was contrary to the instructions in the provided operator's manual.Therefore, use error caused or contributed to this event.A customer in-service was requested.

• Brand Name: VASCULAR POSITIONING SYSTEM
• Type of Device: VPS G4 SYSTEM
• Manufacturer (Section D): VASONOVA INC.; menlo park CA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 2400 bernville road; reading PA 19605
• Manufacturer Contact: john george ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 4929854
• MDR Text Key: 19352047
• Report Number: 2518433-2015-00007
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123813
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VPS-G4C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention